Durata Therapeutics, Inc.
DRTX announced today that DALVANCE (dalbavancin) for injection is now
available for use to treat adult patients with acute bacterial skin and skin
structure infections (ABSSSI). DALVANCE was approved by the U.S. Food and Drug
Administration (FDA) on May 23, 2014 and was the first drug approved as a
Qualified Infectious Disease Product (QIDP). Durata began shipping DALVANCE to
its distributors earlier this week. Physicians and Pharmacists may now order
DALVANCE from ASD Healthcare or their wholesaler, or they may call Durata at 1
855 DURATA1 (1-855-387-2821).
"DALVANCE's unique dosing regimen offers a new approach to treatment of
serious skin infections by allowing patients, healthcare professionals and
hospitals to move beyond the standard daily or twice-daily IV antibiotic
infusions," said Paul R. Edick, Durata's CEO. "We are very pleased that
DALVANCE is now available to millions of Americans who may benefit from this
innovative treatment option for ABSSSI."
For the six-month period of January to June 2010, a projected 9.2 million
patients were treated in U.S. hospitals for infections of any type, and nearly
17 percent of the diagnostic category presentations were for skin and skin
structure infections (SSSI). Of these presentations for SSSI, approximately 74
percent were disease types included in ABSSSI. This category of infection
increased by 176 percent from 1997 to 2009 in hospitalized patients. The
majority of skin and soft tissue infections in hospitalized patients are
caused by Staphylococcus aureus, and approximately 59 percent of these
infections are estimated to be caused by MRSA in the U.S. Effective early
treatment of ABSSSI is critical to prevent wound expansion and to avoid
lengthy and costly hospital stays. Failure to successfully treat ABSSSI may
result in hospital readmissions.
"Managing the daily treatment of ABSSSI can be a difficult task for hospitals,
physicians and patients," said John Shannon, Durata's Chief Commercial
Officer. "We are very proud and excited to have hired, trained, and deployed
over 100 outstanding commercial professionals to communicate the value of
DALVANCE and its unique once-a week dosing for two weeks."
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